Alpharadin in breast cancer patients with bone dominant disease v1.0

• Research type

  Research Study

• Full title

  An open-label Phase 2a, non-randomised, study of Alpharadin in breast cancer patients with bone dominant disease no longer considered suitable for endocrine therapy.

• IRAS ID

  25818

• Contact name

  Robert Coleman

• Sponsor organisation

  Algeta ASA

• Eudract number

  2009-012189-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Alpharadin in breast cancer patients with bone dominant disease:Carcinoma of the breast is the most prevalent cancer in women in the United States and Western Europe and is commonly associated with metastatic bone disease. The median survival time after initial diagnosis of bone metastasis in breast cancer is approximately two years. A few approved treatments are available, but these have not changed the overall prognosis to any large extent. In addition, most approved treatments are associated with substantial side effects. Alpharadin has shown substantial clinical benefit in hormone-refractory prostate cancer patients with skeletal metastases, including statistically significant effects on biomarkers and overall survival. The previous trial data also showed that Alpharadin had a benign adverse event profile. The present study will be initiated to further provide exploratory data for the clinical potential of Alpharadin. The target population is 20 patients with breast cancer who have predominantly bone metastases and who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy.The treatment consists of a maximum of four intravenous injections of Alpharadin, with each dose being separated by an interval of four weeks. Follow up assessments will occur at 16 weeks and at 6, 9 and 12 months after the first dose. Standard supportive concomitant medications are permitted throughout the treatment period, but cytotoxic chemotherapy and other systemic radioisotopes will be delayed until the follow up period.Blood samples for safety tests will be taken at least fortnightly until Week 16, then at the 6, 9 and 12 month follow up visits. Blood and urine samples for biomarker analysis and to measure circulating tumour cells will be taken periodically. Patients will be asked to complete a pain questionnaire at regular intervals. Body/bone imaging will be performed before and during the treatment period.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/58

• Date of REC Opinion

  24 Jan 2010

• REC opinion

  Further Information Favourable Opinion